Complementary technology to orbital atherectomy expands CSI’s vessel prep market opportunity

Cardiovascular Systems, Inc. (CSI^®) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, announced today it has made significant progress towards the commercialization of intravascular lithotripsy (IVL) systems for the treatment of calcific coronary and peripheral artery disease.

Lithotripsy is a medical procedure that uses non-invasive high-pressure waves to fracture and disrupt pathologic solid masses. Lithotripsy has been used successfully for many years in the treatment of kidney and gall stones, and more recently has found application in treatment of calcified coronary and peripheral arteries.

Feasibility testing of a proprietary console and associated IVL balloon catheters is complete. The CSI IVL systems are designed to improve upon the limitations of incumbent technology, allowing physicians to cross and treat more challenging atherosclerotic lesions.

Commercialization of the IVL systems will be highly complementary to CSI’s broader portfolio of advanced vessel preparation technologies.

In coronary, CSI’s current product offering, which is focused on the treatment of severely calcified coronary arteries using orbital atherectomy, targets 12% of percutaneous coronary interventions (PCI). The addition of a coronary IVL system will enable CSI to offer products that effectively treat a broader range of calcific coronary lesions, tripling CSI’s total addressable market (U.S.) to $1.3 billion. Enrollment of patients in an investigational device exemption study for the CSI coronary IVL system is currently targeted for calendar 2023.

CSI’s peripheral orbital atherectomy devices are primarily used by physicians to treat long, diffuse calcified arteries below the knee. Introducing a peripheral IVL system to the CSI offering will expand its treatable patient population across an even broader spectrum of calcified arteries above and below the knee, thereby increasing CSI’s addressable market (U.S.) by over 50% to nearly $1 billion. CSI plans to begin first in-human experience for the peripheral IVL system in calendar 2023.

Scott R. Ward, Chairman, President and CEO, said, “The development of an IVL system for the treatment of coronary and peripheral artery disease will uniquely position CSI to provide the right device, for the right lesion, for all physicians. We believe the successful execution of this program will greatly expand patient access to care and CSI’s overall market position in complex coronary and peripheral disease.”

About Cardiovascular Systems, Inc.

Cardiovascular Systems, Inc., based in St. Paul, Minn., is a medical device company focused on developing and commercializing innovative solutions for treating vascular and coronary disease. The company’s orbital atherectomy system treats calcified and fibrotic plaque in arterial vessels throughout the leg and heart and addresses many of the limitations associated with existing surgical, catheter and pharmacological treatment alternatives. For additional information, please visit www.csi360.com and connect on Twitter @csi360.

About Coronary Artery Disease (CAD)

CAD is a life-threatening condition and a leading cause of death in men and women globally. CAD occurs when a fatty material called plaque builds up on the walls of arteries that supply blood to the heart. The plaque buildup causes the arteries to harden and narrow (atherosclerosis), reducing blood flow. The risk of CAD increases if a person has one or more of the following: high blood pressure, abnormal cholesterol levels, diabetes, or family history of early heart disease. According to the Centers for Disease Control and Prevention, 18 million people in the United States have CAD, the most common form of heart disease. Heart disease claims more than 650,000 lives in the United States each year. According to estimates, arterial calcium is present in 38 percent of patients undergoing a PCI. Significant calcium contributes to poor stent delivery, expansion and wall apposition leading to poor outcomes and higher treatment costs in coronary interventions when traditional therapies are used, including a significantly higher occurrence of death and major adverse cardiac events (MACE).

About Peripheral Artery Disease (PAD)

Eighteen to 20 million Americans, most over age 65, suffer from PAD, which is caused by the accumulation of plaque in peripheral arteries reducing blood flow. Symptoms include leg pain when walking or at rest. Left untreated, PAD can lead to severe pain, immobility, non-healing wounds and eventually limb amputation. With risk factors such as diabetes and obesity on the rise, the prevalence of PAD is growing at double-digit rates.

Safe Harbor

Certain statements in this news release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and are provided under the protection of the safe harbor for forward-looking statements provided by that Act. For example, statements in this press release regarding (i) the development of new IVL systems; (ii) targeted milestones in calendar 2023; (iii) the benefits of IVL and the new IVL systems; (iv) the ability of CSI to successfully develop the IVL systems; (v) the future impact of adding the IVL systems to CSI’s portfolio; and (vi) potential addressable market sizes and expansion of market opportunities, are forward-looking statements. These statements involve risks and uncertainties that could cause results to differ materially from those projected, including, but not limited to, successful collaboration on the development of the new IVL systems; agreements with development partners, advisors and other third parties; the ability of CSI and these third parties to meet development, contractual and other milestones; contractual rights and obligations; technical challenges; regulatory developments; clinical trial requirements and results; FDA requirements, clearances and approvals; the experience of physicians regarding the effectiveness and reliability of products sold by CSI; the reluctance of physicians, hospitals and other organizations to accept new products; the impact of competitive products and pricing; intellectual property protections; general economic conditions; and other factors detailed from time to time in CSI’s SEC reports, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. CSI encourages you to consider all of these risks, uncertainties and other factors carefully in evaluating the forward-looking statements contained in this release. As a result of these matters, changes in facts, assumptions not being realized or other circumstances, CSI's actual results may differ materially from the expected results discussed in the forward-looking statements contained in this release. The forward-looking statements made in this release are made only as of the date of this release, and CSI undertakes no obligation to update them to reflect subsequent events or circumstances.

CSI is a registered trademark of Cardiovascular Systems, Inc. All other trademarks cited herein are owned by their respective owners.

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